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Sponsors and Collaborators: |
SELARL du Dr Jacques BUVAT Bayer |
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Information provided by: | SELARL du Dr Jacques BUVAT |
ClinicalTrials.gov Identifier: | NCT00244023 |
30 to 50% of the patients presenting with Erectile Dysfunction (ED) do not respond to PDE V Inhibitor therapy, which is presently considered as the first choice treatment for most ED patients. Recent reports stated a high prevalence of low serum testosterone levels in such non responders, and an improvement of their response by combining testosterone therapy with the PDE V Inhibitor. This suggests there may be a minimum threshold level of blood testosterone for a full effectiveness of PDE V Inhibitor therapy. Two double blind, placebo controlled studies have added support to this hypothesis but one involved only 20 patients while in the other the benefit of combining testosterone was transient. This is a multi-centric study, double blind placebo controlled and randomized as concerns testosterone administration, that aims to objectively assess the efficacy of co-administering testosterone with the PDE 5 inhibitor Tadalafil to improve the erectile function of a large group of ED patients non-responders to PDE V inhibitors alone. Patients will be screened to ensure inclusion and exclusion criteria completion, including a serum testosterone level < 4 ng/ml for total testosterone or < 1 ng/ ml for bioavailable testosterone. They will then enter a four week run-in period in the meanwhile they will receive Tadalafil 10 mg only, once daily, in order to confirm their non responsiveness to PDE V inhibitors and their eligibility to enter the treatment phase based on IIEF scoring, SEP diaries and a Global Assessment Question (GAQ). The patients still non responders after 4 weeks of Tadalafil 10 mg daily will enter a 12 weeks treatment phase including visits at weeks 4, 8, 12 and 16. Treatment procedure will include: 1. continuation of Tadalafil at 10 mg dose daily followed by routine assessment using SEP diaries, IIEF scoring, GAQ and Aging Male Symptoms scale administered at each study visit. Safety assessments will be performed in addition during the last visit (physical examination including DRE, PSA and BCC). 2. Randomization in 2 parallel arms (Placebo gel + Tadalafil 10 mg daily, and Testosterone gel 50 mg + Tadalafil 10 mg daily). If indicated according to suboptimal clinical response of the patient, the dose of study medication will be increased at the 8 or 12 weeks visit to 100mg of testosterone or to 2 sachets of placebo gel. Up to 430 patients will be screened in order that 172 are enrolled in the double blind treatment phase.
Condition | Intervention | Phase |
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Erectile Dysfunction Hypogonadism |
Drug: Testosterone gel Drug: testosterone Other: placebo gel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Double-Blind, Placebo Controlled Randomized Study of Co-Administering Testosterone With PDE5 Inhibitors in Patients Non-Responders to PDE5 Inhibitors Alone |
Enrollment: | 173 |
Study Start Date: | October 2005 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Testosterone gel (intervention)
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Drug: Testosterone gel
one sachet of 50 mg applied once a day, possibly titrated to two sachets if insufficient improvement of erectile function
Drug: testosterone
testosterone gel, one sachet of 50 mg applied once a day, possibly titrated to 100 mg if insufficient effect
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2: Placebo Comparator
one sachet of placebo gel once a day, possibly titrated to 2 sachets if insufficient efficacy
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Other: placebo gel
one sachet of placebo gel once a day possibly titrated to 2 sachets if insufficient efficacy
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Ages Eligible for Study: | 45 Years to 80 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Concurrent use of the following medications:
androgens including dehydroepiandrosterone (DHEA) and anabolic steroids, antiandrogens, estrogens, corticotrophin (ACTH), oxyphenylbutazone, clomipramine, Serotonin Reuptake Inhibitors, long or short-acting nitrates, NO donors, potent cytochrome P3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, saquinavir, macrolides like erythromycin), cancer chemotherapy;
France | |
CETPARP/SelarlJBuvat | |
LILLE, France, 59000 |
Study Chair: | Jacques BUVAT, MD | SELARL du Dr Jacques BUVAT |
Principal Investigator: | Eugene PLAS, MD | Lainz Hospital Vienna - Austria |
Principal Investigator: | Claude SCHULMAN, MD | Erasme Hospital Brussels |
Principal Investigator: | Francois GIULIANO, MD | Hopital Raymond Poincaré - Garches - France |
Principal Investigator: | Béatrice CUZIN, MD | CHU Edouard Herriot - Lyon - France |
Principal Investigator: | Marie Hélène COLSON, MD | Centre du Palais - Marseille - France |
Principal Investigator: | Hartmut PORST, MD | Urological Office - Hamburg - Germany |
Principal Investigator: | Christian STIEF, MD | Ludwig Maximilians Universität - Munchen - Germany |
Principal Investigator: | Aksam YASSIN, MD | Urological Office - Hamburg - Germany |
Principal Investigator: | Theodor KLOTZ, MD | Klinikum fur Urologie - Weiden - Germany |
Principal Investigator: | Francesco MONTORSI, MD | Hospital San Raffaele - Milano - Italy |
Principal Investigator: | Mario MAGGI, MD | Andrology Unit - Florence - Italy |
Principal Investigator: | Anti KAIPIA, MD | Gynecologi - Ja Urologikeskus - Tampere - Finland |
Principal Investigator: | Eric MEULEMAN, MD | Free University Medical Center - Amsterdam - The Netherlands |
Principal Investigator: | Antonio MARTIN MORALES, MD | Hospital Carlos Haya - Malaga - SPAIN |
Principal Investigator: | Ignacio MONCADA, MD | Hospital Gregorio Maranon - Madrid - SPAIN |
Principal Investigator: | John DEAN, MD | Salisbury Clinic - Plymouth - UK |
Principal Investigator: | Ian EARDLEY, MD | Leeds Hospital - Leeds - UK |
Principal Investigator: | Jacques BUVAT, MD | CETPARP - Lille - France |
Responsible Party: | SELARL du Dr Jacques Buvat ( Jacques Buvat ) |
Study ID Numbers: | TADTEST |
Study First Received: | October 23, 2005 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00244023 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Erectile Dysfunction Testosterone Testosterone Therapy PDE V Inhibitor Tadalafil |
Sexual Dysfunctions, Psychological Antineoplastic Agents, Hormonal Gonadal Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Methyltestosterone Genital Diseases, Male Hormones Testosterone 17 beta-cypionate |
Anabolic Agents Testosterone Hypogonadism Sexual Dysfunction, Physiological Mental Disorders Tadalafil Endocrinopathy Erectile Dysfunction Androgens |
Sexual Dysfunctions, Psychological Antineoplastic Agents, Hormonal Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Methyltestosterone Genital Diseases, Male Hormones Sexual and Gender Disorders |
Pharmacologic Actions Testosterone 17 beta-cypionate Anabolic Agents Testosterone Hypogonadism Sexual Dysfunction, Physiological Mental Disorders Therapeutic Uses Erectile Dysfunction Androgens |